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Anatomic Pathology (AP) is the study of solid tissue, and is often a critical part of many protocols. Tissue samples are used in clinical trials in addition to the usual blood and urine samples. Examples of anatomic pathology samples Covance Central Laboratory Services receives for clinical trials are tissue from the gastrointestinal and urinary tracts, endometrium, liver, skin, lung and bone marrow.

Accurate patient identification is of utmost importance when sending Anatomic Pathology specimens as in almost all cases, unlike blood or urine samples, solid tissue samples cannot be recollected. Therefore the audit trail must be tighter and specimen ID is held to the highest standard. Imperfect specimen ID may result in the specimen being returned to the investigator site.

Tissue samples can be submitted in various forms; Wet tissue, Tissue in a paraffin block, or Tissue on a slide.
Some tissue samples are newly obtained from patients during the course of a clinical trial. These fresh samples are normally submitted “wet” in formalin.

They are identified with the barcode accession number affixed to the Covance CLS provided sample container and the Patient ID written on the label and the requisition. Be sure to write the patient ID using indelible marker on the accession label that matches the requisition.

Some tissue samples may be submitted from an archive of tissue samples from a patient. These archival samples may be already labeled using local hospital or clinical procedures. When the Sponsor wants to use these tissues for analysis, it is extremely important to provide a durable and defensible audit trial….tying the local patient identifiers to the Covance accession number used in the clinical trial.

Some tissue samples may be submitted from an archive of tissue samples from a patient. These archival samples may be already labeled using local hospital or clinical procedures. When the Sponsor wants to use these tissues for analysis, it is extremely important to provide a durable and defensible audit trial….tying the local patient identifiers to the Covance accession number used in the clinical trial.

Archival AP samples are normally submitted along with a copy of the local pathologist’s report which includes the sample’s local identification. Use the extra accession label from within the Covance CLS kit and apply it to the local lab report. This ties the local lab report to the clinical trial. Handwrite the patient’s clinical trial patient number or initials on the label. Also, be sure to use a black marker to obscure any confidential information such as patient’s name, address, social security number, etc.

In a sampling of specimens received at Covance CLS, we found AP sample identification errors to be 10 times the error rate for blood and urine samples! In order to preserve unique tissue samples we want to share successful practices with you. These will reduce the error rate ensuring the sample can be used for inclusion and analysis in the clinical trial. Please review the eLearning on Anatomic Pathology Sample ID for tips in proper labeling to prevent common sample identification errors.

By working together, we can reduce specimen identification errors and increase delivery of accurate results. Careful attention to specimen identification promotes quality patient care and a successful clinical trial.

A project number is another way to identify your Covance protocol. This information is particularly useful when ordering kits and supplies as it identifies which arm/phase/branch/region applies to your study. Project numbers are six-digits long and can be found on the cover of your Covance Laboratory Manual and on every requisition in the left, lower corner.

Covance Central Laboratory Services recommends centrifuging specimens at 1500-2000g for 15 minutes. Failure to follow this suggestion could result in hemolysis, fragmentation of platelets, formation of microclots/clots, variability in results and an increased number of cancelations.

Should you need to make changes to this recommendation, please contact the study Sponsor in case of possible negative impacts in study data.

We’ve created a series of videos and guides to demonstrate how to properly package and ship your specimens to Covance for testing. The brief videos cover ambient, refrigerated, frozen, and combo sample packaging as well as how to use our gel packs.

Please check kit expiration dates before using them. Some tubes used for sample collection have expiration dates. These dates are defined by the tube manufacturers.

To ensure the validity of the tubes contained in the collection kit, expiration dates are printed on the outside of the kit box. The expiration date of each kit corresponds to the shortest expiration date of the tube(s) within the kit.

Please do not collect specimens in expired containers! Specimens received in an expired container which includes an additive will be canceled as: “Sample drawn in expired tube: Testing not performed.”

If you have expired tubes please use the online web tool at http://www.covance.com/kitordering or call Covance Central Laboratory Services to have these kits replaced and your inventory updated. Note: Using the online tool is the preferred method for tracking purposes.

Did you receive a fax or voicemail concerning a High Panic or Low Panic lab value?

Please respond as soon as possible to confirm receipt of that lab value, as failure to do so can result in an escalation to the sponsor. Remember, Investigator Support can be reached by phone, email and fax.

The phone number and fax numbers are located in your Covance Lab Manual.

Some studies, but not all, will have auto resupply. In order to trigger this service, sites need to notify Covance when you have an expired or damaged kit. It is important to keep your kit inventory updated in order to have auto resupply orders trigger properly. You can notify us about your kit inventory via the kit order website: http://www.covance.com/kitordering. Please fill out the required fields and write the kit name and inventory number under the comments section.

If you have contacted Covance Inc. to request a change to the collection date, collection time, patient gender, etc., please know that this request can take from 3 to 7 business days. Once the change is completed, a fax notification will be sent to the investigator confirming the revision is done.

As the heat of summer is upon us, it is an opportune time to review the steps necessary to prepare frozen samples for shipment.

Covance has created the attached video to ensure that you are equipped to prepare frozen samples for shipment to Covance. It is critical that these steps be followed so that frozen samples remain frozen during the transit to Covance. If the samples thaw, they may not be stable for analysis, leading to possible lost data.